Clinical Trials /

Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

NCT04725903

Description:

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor and nearby lymph nodes, is an effective way to treat patients with high-risk prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy. The information learned from this study may also help researchers to learn more about proton therapy for the treatment of patients with prostate cancer.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04725903

Trial Eligibility

Document

Title

  • Brief Title: Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
  • Official Title: Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: STUDY00000329
  • SECONDARY ID: NCI-2020-07113
  • SECONDARY ID: RAD5131-20
  • SECONDARY ID: P30CA138292
  • NCT ID: NCT04725903

Conditions

  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8

Purpose

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor and nearby lymph nodes, is an effective way to treat patients with high-risk prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy. The information learned from this study may also help researchers to learn more about proton therapy for the treatment of patients with prostate cancer.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical
      photon treatments.

      SECONDARY OBJECTIVES:

      I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical
      photon treatments.

      II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.

      III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.

      IV. To determine patient-reported outcomes (PROs) of toxicity.

      OUTLINE:

      Patients undergo pelvic proton beam therapy daily on Monday-Friday for 5-7 weeks. Patients
      may receive a high-dose rate brachytherapy boost.

      After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months,
      and 1.5, 2, 2.5, and 3 years.

Trial Arms

NameTypeDescriptionInterventions
Treatment (proton beam therapy)ExperimentalPatients undergo pelvic proton beam therapy daily on Monday-Friday for 5-7 weeks. Patients may receive a high-dose rate brachytherapy boost.

    Eligibility Criteria

            Inclusion Criteria:

          -  Pathologically confirmed high-risk prostate cancer fulfilling any one of the following
             criteria:

               -  Gleason grade 8 or higher

               -  cT3b (seminal vesicle involvement) or cT4

               -  Prostate specific antigen [PSA] > 20 (or PSA >10 if on finasteride)

               -  Clinically or pathologically positive regional lymph nodes within the inguinal,
                  external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac,
                  or lower para-oaortc (inferior to the L2-L3 interspace) basins

          -  Absence of bone metastasis by CT, MRI, bone scan or metabolic imaging (e.g. F-18
             sodium fluoride positron emission tomography [NaF PET],
             anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC] PET, etc) within 90
             days prior to registration

          -  Absence of distant lymph node metastasis

          -  Zubrod performance status 0-2

          -  Complete blood cell (CBC)/differential obtained within 60 days prior to registration
             on study

          -  Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 60 days prior to
             registration on study)

          -  Platelets >= 100,000 cells/mm^3 (obtained within 60 days prior to registration on
             study)

          -  Hemoglobin >= 8.0 g/dl (obtained within 60 days prior to registration on study) (Note:
             The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl
             is acceptable)

          -  Patient must be able to provide study specific informed consent

        Exclusion Criteria:

          -  Distant metastasis

          -  Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

          -  Prior radiotherapy, including brachytherapy, to the region of the study cancer that
             would result in overlap of radiation therapy fields

          -  Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel
             disease, human immunodeficiency virus infection, ongoing or active infection,
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations that would limit compliance with study
             requirements
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Acute grade 2+ gastrointestinal (GI) toxicity
    Time Frame:Up to 3 years
    Safety Issue:
    Description:The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.

    Secondary Outcome Measures

    Measure:Acute grade 2+ genitourinary (GU) toxicity rate
    Time Frame:Up to 3 years
    Safety Issue:
    Description:The rate of grade 2+ genitourinary toxicity within 30 days of receiving radiation therapy (RT) will be measured. Assessments are based on version 5 CTCAE, and the worst severity of GU toxicity will also be assessed.
    Measure:Optimal frequency of cone beam computed tomography (CT)
    Time Frame:Through study completion, an average of 1 year
    Safety Issue:
    Description:Will determine the optimal frequency of cone beam CT during treatment and assess subsequent need for adaptive re-planning. The feasibility of extended-field proton irradiation of high-risk prostate cancer will be estimated using a re-planning rate of less than 10%. The re-planning rate will be estimated as binary variable, yes or no. The exact 95% confidence interval (CI) around the 10 % re-planning count based on the binomial distribution for the estimated 30 patients will be used (0.021-0.265). The study will be deemed feasible if the observed rate is not higher than the upper bound of the estimated 95% CI.
    Measure:Patient reported health related quality of life (QOL) - PRO-CTCAU GI
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Assessed using Patient Reported Outcomes-CTCAE GI toxicity
    Measure:Patient reported health related quality of life (QOL) - PRO-CTCAU GU
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Assessed using Patient Reported Outcomes-CTCAE GU toxicity
    Measure:Patient reported health related quality of life (QOL) - IPSS
    Time Frame:Up to 3 years
    Safety Issue:
    Description:International Prostate Symptom Score (IPSS)
    Measure:Patient reported health related quality of life (QOL) - EPIC-CP
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
    Measure:Chronic GI Toxicity
    Time Frame:Up to 3 years
    Safety Issue:
    Description:The rate of any grade gastrointestinal toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.
    Measure:Chronic GU Toxicity
    Time Frame:Up to 3 years
    Safety Issue:
    Description:The rate of any grade genitourinary toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GU toxicity will be assessed.
    Measure:Biochemical failure
    Time Frame:Baseline up to pre-RT
    Safety Issue:
    Description:Assessed by the Phoenix definition (prostate specific antigen [PSA] >= 2 ng/ml over the nadir PSA).

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Emory University

    Last Updated

    March 8, 2021